HIPAA, 21CFR part 11 and Extended Security

PAX-it manages an imaging workflow with tools for image acquisition, archiving, annotation, sharing, reporting, image analysis and more, in a network environment. Entire projects are managed, including non-image files, reports and documents, image analysis data and other digital file types.

PAX-it does not just “point” to files that are tracked in Windows® Explorer, as is done by  image catalogs.   Instead, the PAX-it application maintains the collection and manages its assets via our database tools. Since user logins with passwords can be required to enter PAX-it, the associations between an image and its related data (including accession/case numbers, demographics, notes, overlays, etc.) are only accessible to authorized users, fulfilling the key HIPAA requirements.

An administrator may grant certain rights or permissions to PAX-it users according to their login ID’s, protecting the database from unwanted or inadvertent image deletion or tampering with data.

In addition, PAX-it allows for particular areas of the collection (drawers and/or folders) to be locked with passwords, restricting access even further if necessary. These locks may be set to allow anyone without the password to ‘view only’ (no editing), or can completely prevent entry into a locked area.

The PAX-it Extended Security module is available for even tighter security controls, including digital signatures and audit trails for 21CFR Part 11 compliance or other corporate administration of security policies.

password protected thumb folders

    • Do your images or reports contain private or sensitive information that should be locked down?
    • Do you need to demonstrate and validate in court that images have not been tampered with?
    • Is your department audited by government agencies for policies and procedures (such as FDA 21CFR Part 11)?
    • Do you need to know when security breaches have occurred?
    • Would you like to verify data, reports, and analytical results as authentic and unaltered?

 If you answered ‘Yes’ to any of these questions, the PAX-it Extended Security (ES) Module is the right choice for you.

 PAX-it’s module for Extended Security is designed for the user requiring tools  for digital signatures (electronic signatures / electronic records), 21CFR Part 11 compliance, or for anyone desiring more strict  control over access to the PAX-it database assets.   The ES module is an add-on component to a PAX-it network site license set up as an MS SQL-Server or Oracle database (database license is not included).

 The Extended Security Module addresses security through three main components:

Administrative Tools: By assigning privileges to users based on who they are or their level of project involvement, unscrupulous or inadvertent unwanted activity can be hindered or avoided from the start.

authenticity check

Digital Signatures: Used to stamp an image or other file as “authentic” or “valid”.  Assets with digital signatures are locked down so that further changes are not allowed. PAX-it’s electronic signatures go far beyond just making an asset “read only”.

Logging of Audit Trails: Allows administrators to track activities related to image or document manipulation, including moving, deleting, editing, and adjusting.

 


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